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Having been in the clinical lab (pathology) field when they implemented
CLIA for U.S. Army laboratories, I can tell you that parts of it are a pain
in the posterior.

To join Robert Loesch in the "devil's advocate" corner, I fear that
somewhere along the line it will be determined that bioassays performed for
regulatory compliance fall under the category of tests done for the
prevention of disease.

We all know that large acute radiation doses cause damage that leads to
states that could be considered "disease" (e.g. leukemia).  I worry that
the folks running the CLIA show will adopt the EPA's apparent attitute that
any radiation exposure above zero is unacceptably dangerous.  If they do
so, they will be able to classify all exposures, no matter how small, as
potential disease-causing incidents.  Imagine having even your routine
bench-frisking classified as a test done to prevent disease...

Want to push a step farther (not probable, but possible)?  Interpret the
phrase "materials derived from the human body" as including materials
originating in and emitted by the human body and you not only cover saliva,
urine and feces, but also exhalations and detectable radiation from
internalized sources.  Suddenly every lab in the country whose samples have
even the slightest link to a "patient" is under CLIA.

Be afraid...

J. Eric Denison
Program Assistant to the Director
Neurobiotechnology Center
The Ohio State University
206 Rightmire Hall
1060 Carmack Road
Columbus, Ohio  43210
ph: 614-292-5682
e-mail: denison.8@osu.edu